Description and Brand Names

US Brand Name

Canadian Brand Name

Descriptions

Valproate sodium injection is used to treat certain types of seizures (epilepsy). This medicine is an anticonvulsant that works in the brain tissue to stop seizures.

This medicine is to be given only by or under the direct supervision of your doctor.

This product is available in the following dosage forms:

Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of valproate sodium injection in children. However, safety and efficacy have not been established in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of valproate sodium injection in the elderly. However, elderly patients are more likely to have unwanted effects (eg, tremors or unusual drowsiness), which may require an adjustment in the dose for patients receiving valproate sodium injection.

Pregnancy

Information about this valproate-sodium-intravenous-route

Pregnancy Category

Explanation

All Trimesters

X

Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Amifampridine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Amitriptyline

Cisplatin

Desvenlafaxine

Dolasetron

Doripenem

Ertapenem

Fentanyl

Fluoxetine

Granisetron

Hydroxytryptophan

Imipenem

Ketorolac

Lamotrigine

Levomilnacipran

Lorcaserin

Meperidine

Meropenem

Mirtazapine

Orlistat

Palonosetron

Primidone

Tramadol

Trazodone

Vorinostat

Vortioxetine

Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acyclovir

Aspirin

Betamipron

Carbamazepine

Cholestyramine

Clomipramine

Erythromycin

Ethosuximide

Felbamate

Fosphenytoin

Ginkgo

Lorazepam

Mefloquine

Nimodipine

Nortriptyline

Olanzapine

Oxcarbazepine

Panipenem

Phenobarbital

Phenytoin

Rifampin

Rifapentine

Risperidone

Ritonavir

Rufinamide

Topiramate

Zidovudine

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Congenital metabolism disorders (born with a disease that affects metabolism) or

Mental retardation with severe seizure disorders—Use with caution. May increase risk for more serious side effects.

Proper Use

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins. This medicine is given slowly, so the needle will remain in place for about an hour.

Your doctor will only give you a few doses of this medicine until your condition improves. You will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions

It is very important that your doctor check your progress closely while you are using this medicine to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

Using this medicine while you are pregnant (especially during the first trimester) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

It is very important to take folic acid before getting pregnant and during early pregnancy to lower chances of harmful side effects to your unborn baby. Ask your doctor or pharmacist for help if you are not sure how to choose a folic acid product.

Liver problems may occur while you are using this medicine, and some may be serious. Check with your doctor right away if you are having more than one of these symptoms: abdominal or stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Check with your doctor right away if fever, sore throat, rash, ulcers in the mouth, nosebleeds, bleeding gums, swollen glands, or small red or purple spots on the skin occur. These could be symptoms of a serious blood problem.

Check with your doctor right away if you are having unusual drowsiness, dullness, tiredness, weakness or feelings of sluggishness, changes in mental status, low body temperature, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.

Check with your doctor if you have unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness, confusion, trouble concentrating, memory problems, trouble walking, talking, or eating, or loss of consciousness while using this medicine.

Valproate sodium injection may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that cause drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures (eg, barbiturates), muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

bloating or swelling of the face, arms, hands, lower legs, or feet

blood in the urine or stools

chest pain

chills

confusion

cough or hoarseness

crying

delusions

dementia

depersonalization

diarrhea

dysphoria

euphoria

fever or chills

general feeling of discomfort or illness

headache

joint pain

loss of appetite

lower back or side pain

mental depression

muscle aches and pains

nausea

painful or difficult urination

paranoia

pinpoint red spots on the skin

quick to react or overreact emotionally

rapid weight gain

rapidly changing moods

runny nose

shakiness and unsteady walk shakiness in the legs, arms, hands, or feet

shivering

sleepiness or unusual drowsiness

sore throat

sweating

tingling of the hands or feet

trembling or shaking of the hands or feet

trouble sleeping

unsteadiness, trembling, or other problems with muscle control or coordination

pains in the stomach, side, or abdomen, possibly radiating to the back

passing urine more often

pounding in the ears

small red or purple spots on the skin

sneezing

sore throat

stuffy nose

tightness in the chest

vomiting of blood or material that looks like coffee grounds

yellow eyes or skin

Rare

False or unusual sense of well-being

feeling faint, dizzy, or lightheadedness

feeling of warmth or heat

flushing or redness of the skin, especially on the face and neck

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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